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Home » Drug Information » FDA Approved Drugs » 2010
Medical Areas: Cardiology/Vascular Diseases | Family Medicine

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Tekamlo (aliskiren + amlodipine)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Novartis
Approval Status: Approved August 2010
Treatment Area: hypertension

General Information

Tekamlo is a single tablet combining aliskiren, an orally active, nonpeptide, potent direct renin inhibitor and amlodipine, a dihydropyridine calcium channel blocker.

Tekamlo was specifically indicated for the treatment of hypertension: as initial therapy, in patients not adequately controlled with monotherapy (either of the components alone) and as a substitute for its titrated components.

Tekamlo is supplied as a tablet designed for oral administration. The recommended initial dose is as follows:
Initial Therapy
150 mg/5 mg once daily. It can be titrated as needed to a maximum of 300 mg/10 mg.
Add-on Therapy
Switch a patient who experiences dose-limiting adverse reactions on either component alone to Tekamlo containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions.
Replacement Therapy
Switch patients receiving aliskiren and amlodipine besylate from separate tablets to a single tablet of Tekamlo containing the same component doses. When substituting for individual components, increase the dose of one or both of the components if blood pressure control has not been satisfactory.

Clinical Results

FDA Approvals
The FDA approval of Tekamlo was based on clinical trial data involving more than 5,000 patients with mild-to-moderate high blood pressure.
Study One
An eight-week, randomized, double-blind, placebo-controlled, multi-factorial study showed that the combination of Tekturna and amlodipine resulted in decreases in systolic/diastolic blood pressure at trough of 14-17/9-11 mmHg, compared to 4-9/3-4 mmHg for Tekturna alone, and 9-14/6-8 mmHg for amlodipine alone.
Study Two
This double-blind, active-controlled study enrolled 443 African-Americans with moderate-to-severe high blood pressure (SBP 160 - 200 mmHg). The systolic/diastolic treatment difference between Tekamlo and amlodipine was 5.2/3.8 mmHg at eight weeks.
Study Three
This double-blind, active-controlled enrolled 484 subjects with moderate-to-severe high blood pressure (SBP 160 - 200 mmHg). The treatment difference between Tekamlo and amlodipine was 7.1/3.8 mmHg at endpoint.

Side Effects

Adverse events associated with the use of Tekamlo may include, but are not limited to, the following:

  • peripheral edema
  • angioedema
  • diarrhea
  • arrhythmia
  • neuropathy
  • gastrointestinal
  • respiratory

Mechanism of Action

Tekamlo is a single tablet combining aliskiren, an orally active, nonpeptide, potent direct renin inhibitor and amlodipine, a dihydropyridine calcium channel blocker.

Literature References

Littlejohn TW 3rd, Trenkwalder P, Hollanders G, Zhao Y, Liao W Long-term safety, tolerability and efficacy of combination therapy with aliskiren and amlodipine in patients with hypertension. Current medical research and opinion 2009 Apr;25(4):951-9

Additional Information

For additional information regarding Tekamlo or hypertension please visit the Novartis web page.